the market is in its bottom part, more or less. Clearly, in such situation it's hard to choose a good sector, and even harder to choose a particular stock.
From now to the end of the year, the ones which have fallen harder will perform better? or the contrary? that's the question.

FDA issued new draft guidelines that support more flexible regulation around potential design and approval for future early stage Alzheimer's drugs (and ALS, DMD, etc). Should incrementally increase positive thinking around BIIB Aducanumab and future drugs in industry pipeline (with some caveats). **Contact us for full guidance report documents** FDA continues to move towards a more flexible and collaborative regulatory body designed to accelerate drugs to market. From an investment standpoint, we believe draft guidelines for early Alzheimer's (and other diseases including ALS, DMD, migraine, epilepsy) incrementally and particularly benefits BIIB. Overall for investors, this ultimately - could lower the discount rate and slightly raise the probability of success of drugs - reiterating again - the drugs still have to "work". But what defines what is working may be more open for discussion and collaboration which is good for probability of success calculations. While we would not necessarily materially change our thinking on BIIB Aducanumab (60-65% probability of success) and our investor base case is that the study has to positive and hit stat sig to get approved - it certainly could change an investor's "bull case" thinking because the guidelines could suggest the agency could ultimately be more flexible in the end because it has significant impact on reducing a key biomarker (amyloid) and could show some effect on cognition. Thus the Street may increase a view that if the Aducanumab study was "close" to hitting stat sig, and was safe - the agency might have a more positive view than normal. (1) FDA Commissioner Scott Gottlieb seems to be moving the pendulum more towards a collaborative and pro-innovative regulatory body in favor of encouraging development and approval of drugs for serious diseases, the agency released comments that clearly appear to favor collaborative dialog and innovative study designs in early Alzheimer's disease. This may suggest we are in a pro-innovative environment designed to help get drugs to market, not an agency that wants to be a roadblock. (2) Agency appears to want to be flexible with companies on endpoints: FDA suggests that early Alzheimer's disease drugs could be developed by showing benefit on just cognition or an integrated cognition/function endpoint similar to what BIIB is using for A-mab and BAN-2401 Phase II. In addition, studies for early Alzheimer's patients could be designed to look at "time to events analysis" or assessment of disease course (randomized start or randomized-withdrawal design). Importantly - it does suggest that drugs could be approved on biomarkers (for the earliest stage AD) although there is no consensus thinking on which biomarkers are most important - but that sufficient analysis and evidence that key biomarkers are relevant and can be considered - and agency strongly encourages more work and collaboration here. But ultimately our interpretation is anything on biomarkers would need strong supportive cognition evidence - or eventually later in a future study. (3) In ALS disease (BIIB has Phase I/II SOD1 program), we think the separate draft guidance is incremental but less overtly positive compared to Alzheimer's. The document and agency thinking suggests they want to accelerate drugs here but seems to acknowledge that due to heterogeneity and other factors such as lack of credible surrogate markers, traditional placebo-controlled trials are most preferred and need clinically meaningful improvements in symptoms or function, or overall survival and include impact on need for respiratory support (or other outcome endpoints). Other factors help accelerate development however including more flexibility around traditional drug requirements (less preclinical tox requirements) and other testing that can be done later on (cardiac, carcinogenicity, etc).

BiocenturyFDA plans to use a proposed record-setting funding boost to invest in projects it believes could lead to fundamental improvements in the way medical products are tested, reviewed and manufactured. The goal is to use regulatory innovation to help industry create better medicines, manufactured less expensively and more reliably, that reach patients more quickly.

The agency wants to kick-start the transition to advanced manufacturing technologies for drugs, vaccines and cell therapies, fund the creation of natural history databases to accelerate the development of medicines for rare diseases, and use technology to streamline reviews of generic drugs.

The agency also has dusted off its wish list of internal improvements, including a long-sought knowledge management system that could make new drug review decisions more consistent and evidence based.

Some of the proposed budget increase would be put toward establishing an industry for large-scale compounding.

FDA’s plans also could unleash digital health technologies by financing new regulatory approaches that would distinguish between low- and high-risk products as well as streamline product certification.

These and other plans are all based on the Trump administration’s request for Congress to increase FDA’s FY19 budget by about $400 million, which would be the largest increase the agency has ever received, according to the Alliance for a Stronger FDA.

New funding also would allow FDA to design processes for continuous manufacturing of recombinant, cell-based influenza vaccines.To actually get the money, FDA will have to persuade Congress to appropriate it.

The first step is to lay out a compelling case for giving more taxpayer money to an agency that leans heavily on user fees, and traditionally has been neglected by congressional appropriators who are more enthusiastic about funding NIH, the Department of Agriculture and other agencies that have large, vocal constituencies.

One way FDA is making its case is by focusing on programs that advance broad public health priorities and can only be accomplished with taxpayer money. It has identified high-impact projects that companies are not willing to fund through user fees.

The agency’s plans also are predicated on the idea that smart regulation can improve public health and stimulate economic development. While this may be an unusual argument in an administration that is committed to the notion that government regulation is pernicious, FDA’s plans are aligned with contemporary political priorities, including promoting domestic manufacturing and job creation, and removing barriers that slow patient access to new medicines.

CONTINUOUS MANUFACTURINGOne of the biggest and most expensive items on FDA’s wish list is funding R&D of new manufacturing technologies that can move the biopharmaceutical industry away from 20th century batch manufacturing to continuous processes that are common in other sectors.

FDA’s expectation is that continuous manufacturing will lead to higher-quality products, reduce the cost of goods and reduce shortages by creating surge capacity and improving production reliability.

Continuous manufacturing and other advanced manufacturing technologies also tick a number of political boxes.

In a statement about the budget request, FDA Commissioner Scott Gottlieb noted that continuous manufacturing facilities have small footprints and are likely to be built in the U.S.

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